Clinical investigations with medical devices

The information on clinical investigations with medical devices is currently only available in Dutch. However, an English translation is in progress and will be available as soon as possible.

For the time being, we refer you to the information on our website in Dutch. We apologise for the inconvenience.

A guidance document in English for accredited Medical Research Ethics Committees (MRECs) is already available. This guidance sets out the implications of the MDR for the review by the accredited MRECs of clinical investigations with medical devices. It focuses on the quality and safety of medical devices used in clinical investigation, but it also describes the new procedures for submission, assessment and conduct of such studies.